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Indocyanine Green Imaging for Bariatric Surgery

Phase 4

Recruiting

Led By Allan Okrainec

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial studies the use of imaging to assess blood flow during gastric bypass surgery to reduce leaks, ulcers and strictures.

Who is the study for?

This trial is for adults over 18 who are eligible for Roux-en-Y gastric bypass (RYGB) surgery in Ontario and can commit to the bariatric program's follow-up, including lifestyle changes. They must be able to consent and may have had treatment for a marginal ulcer. It excludes those with allergies to indocyanine green or Sodium Iodide, substance abuse/smoking issues, unwillingness to take PPIs post-op, pregnancy plans within two years, or bleeding/coagulation disorders.Check my eligibility

What is being tested?

The study tests if using the Stryker 1688 AIM system along with Indocyanine Green dye helps surgeons see blood flow during RYGB surgery better. The goal is to check if this method reduces complications like ulcers, leaks, and strictures after surgery.See study design

What are the potential side effects?

Potential side effects include allergic reactions to Indocyanine Green such as itching or rash; however specific side effects related directly from its use in this surgical context will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.

Secondary outcome measures

The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).

To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Interventional group (with drug)Experimental Treatment2 Interventions

The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine green

2016

Completed Phase 4

~1720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

484,930 Total Patients Enrolled

13 Trials studying Obesity

937 Patients Enrolled for Obesity

Stryker EndoscopyIndustry Sponsor

4 Previous Clinical Trials

1,730 Total Patients Enrolled

Allan OkrainecPrincipal InvestigatorUniversity Health Network, Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How would the Interventional group fare if prescribed a pharmaceutical?

"With the Interventional group (with drug) being part of a Phase 4 trial, Power's team judges its safety to be at the maximum level 3. This is because it has been officially approved as a treatment option."

Answered by AI

What is the uppermost cap for participants of this clinical trial?

"Yes, indeed. Per the information found on clinicaltrials.gov, this clinical trial is currently enlisting participants and was originally posted on January 25th 2023 with its latest update occurring on August 9th 23rd. The study needs to recruit 250 patients from 1 location."

Answered by AI

Are participants being accepted into this examination at present?

"Indeed, the information published on clinicaltrials.gov indicates that this trial is actively accepting candidates at present. This research program was first posted to the platform on January 25th 2023 and last updated August 9th of the same year. A total of 250 individuals need to be recruited from a single site for successful completion of the study."

Answered by AI